FDA product code CHL: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
CHL is the FDA product code for electrode measurement, blood-gases (pco2, po2) and blood ph. It is a Class II device, regulated under 21 CFR 862.1120 and reviewed by the Clinical Chemistry panel. FDA has cleared 188 510(k) submissions under CHL, 8 in the last five years, from 59 different applicants. The average 510(k) review took 103 days (median 66); 214 days on average over the last three years. FDA has posted 184 recalls for CHL devices, 62 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| Device class | Class II |
| Regulation | 21 CFR 862.1120 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CHL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 59 |
| 2018 | 1 | 215 |
| 2020 | 4 | 116 |
| 2021 | 2 | 354 |
| 2023 | 5 | 371 |
| 2024 | 1 | 246 |
| 2025 | 1 | 127 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every CHL clearance
Top CHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 20 | 2002-12-20 |
| Instrumentation Laboratory CO | 15 | 2021-08-20 |
| Radiometer America, Inc. | 15 | 2000-01-10 |
| Fisher Scientific Co., LLC | 15 | 1983-06-16 |
| Radiometer Medical Aps | 13 | 2016-11-04 |
54 more applicants have CHL clearances. See the full list in Caduvo.
Most recent CHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252207 | Radiometer Medicals Aps | ABL90 FLEX PLUS System, safeCLINITUBES | 2026-04-10 | 270 |
| K244014 | Abbott Point of Care, Inc. | i-STAT CG4+ cartridge with the i-STAT 1 System | 2025-05-02 | 127 |
| K240998 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | 2024-12-13 | 246 |
| K230285 | Abbott Point of Care, Inc. | i-STAT CG8+ cartridge with the i-STAT 1 System | 2023-10-27 | 267 |
| K221900 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | 2023-09-29 | 456 |
Recalls for CHL devices
184 product recalls in 92 recall events; 62 initiated in the last five years and 64 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 11 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 7 |
| 2024 | 11 |
| 2025 | 8 |
| 2026 | 32 |
Frequently asked questions
What is FDA product code CHL?
CHL is the FDA product code for electrode measurement, blood-gases (pco2, po2) and blood ph. It is a Class II device, regulated under 21 CFR 862.1120 and reviewed by the Clinical Chemistry panel.
What device class is CHL?
Class II, regulation 21 CFR 862.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHL?
Across 188 cleared submissions the average was 103 days from receipt to decision (median 66).
Which companies have the most CHL clearances?
Nova Biomedical Corp. (20); Instrumentation Laboratory CO (15); Radiometer America, Inc. (15); Fisher Scientific Co., LLC (15); Radiometer Medical Aps (13).
Have CHL devices been recalled?
Yes: 184 product recalls across 92 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code CHL
- Run a recall and safety report across every CHL manufacturer
- Watch product code CHL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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